Assessment of the Diagnostic and Theranostic Potential of Ga Bombesin PET/CT (NeoB) Imaging for Staging of ER/PR + HER2- Breast Cancer Patients With Metastatic Disease: Comparison to Conventional Imaging

Best TRial

This phase IIb pilot study will enrol 20 patients (women) presenting with metastatic breast cancer (ER/PR + HER2- on histology) who require imaging for staging or re-staging of their disease.

2023-02-20

2025-02-20

2025-02-23

Recruiting

Early phase I

20

Inclusion Criteria: * Female patients aged 18 or above * Ability to provide informed consent documentation indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study * Estrogen/Progesterone receptor +ve HER2 negative disease confirmed on prior biopsy (primary or metastatic site). * Metastatic breast cancer being staged or re-staged prior to treatment of metastatic disease (including those presenting with up-front metastatic disease with primary breast cancer in-situ and those who have progressed on a line of treatment for metastatic breast cancer that are suitable for another line of treatment) * Metastatic breast cancer being staged or restaged prior to change in treatment with standard imaging within 3 weeks of enrolment (CT CAP, bone scan, FDG PET CT) Exclusion Criteria: * Pregnancy or lactation (patients should use highly effective methods of contraception during and for 12h after administration) * Significant inter-current acute illness as per investigator discretion that prevent undertaking study procedures * History of current active malignancy as per investigator discretion other than breast cancer. * Known or expected hypersensitivity to 68Ga NeoB

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Female patients aged 18 or above with ER/PR+ HER2 - metastatic breast cancer presenting for standard of care staging/restaging prior to treatment of metastatic disease.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2023-06-05